Recall Z-0147-06 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
St Jude Medical
Photo Micro VR/DR Models V-194
| Date | Nov 16, 2005 (initiated Oct 6, 2005) |
| Status | Terminated |
| Reason | Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support. |
| Root cause | Other |
| Action | Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005. |
| Quantity | 7696 |
| Distribution | Nationwide and Western Europe: Austria Belgium Denmark Finland France Germany Italy Netherlands Poland Portugal Spain Sweden UK Switzerland Greece Malta Eastern Europe: Czech Republic Lithuania Latvia Romania Bulgaria Croatia Slovenia Slovakia Russia Serbia Middle East! |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.